Oral Nutritional Supplement in Children

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Purpose: 

The objective of this randomized, controlled trial is to evaluate the  effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.               

What to Expect: 

Participation in the oral nutritional supplementation in children study lasts approximately 120 days and includes visits to the study site and regular entries into parent diary. Qualifying participants may be compensated for their time and travel.

Eligibility Criteria: 

• Child is 36 months - 107 months of age.
• Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
• Child's caregiver has voluntarily  signed and dated an informed consent form (ICF), approved by an IRB, and  provided Health Insurance Portability and Accountability Act (HIPAA) or  other applicable privacy regulation authorization prior to any  participation in the study.
• Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
• Child's caregiver is able and willing  to follow study procedures and record data in parent diaries and  complete any forms or assessments needed during the study.
• Child is willing to consume the study product for the duration of the study, if randomized to intervention group

Length / Duration:  

Participation in this study lasts approximately 120 days (4 months) and includes follow up visits to the study site and supervised dosing by parent/legal guardian for children throughout the treatment period and recorded on a parent diary.

Location:  

3229 Hillsdale Lane, Kissimmee, Florida 34741, United States

Who should you contact: 

Recruitment Department: (407) 350-3979